Clinical Trial: Escitalopram Effects on CSF Amyloid Beta

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Escitalopram Effects on CSF Amyloid Beta Total Concentrations

Brief Summary: Alzheimers disease (AD) is a devastating illness, estimated to affect 5 million patients in the United States alone and projected to increase dramatically over the next decades as the population ages unless preventive measures can be developed. The investigators have preliminary evidence that selective serotonin reuptake inhibitor (SSRI) antidepressants lower the amount of amyloid plaques in the human brain. The interventions now propose to study the effects of an SSRI (escitalopram) on levels of amyloid beta peptide (the major constituent of the plaques) in the cerebrospinal fluid (CSF) of cognitively normal older adults. The investigators will measure CSF Amyloid Beta levels before and after two weeks of treatment with escitalopram using a double blind placebo-controlled study design with approximately 30 cognitively normal participants, age 65-85, with a Clinical Dementia Rating scale, [CDR] = 0. They will be recruited from the community. Participants will be randomized (approximately 15 per group). Participants will have three office visits: the first visit will be for screening and consent and participants will be randomized 1:1 to receive escitalopram or placebo for two weeks; the second and the third visits will be for lumbar puncture (LP) and CSF analysis. Each LP visit will take about 2 hours. The second LP will occur two weeks after the first LP. At each LP visit, approximately 1½ tablespoons of blood and 4 teaspoons of CSF will be obtained. Participants randomized to escitalopram will take 10 mg escitalopram for 5 days, then take 20 mg escitalopram for the remainder of the two week exposure period, and then taper down to 10mg for 3 days. The current proposal will test whether clinically relevant doses of an SSRI reduce CSF levels of Amyloid Beta in healthy older human participants. The investigators hypothesize that compared to placebo, participants receiving escitalopram will show significantly lower Amyloid Beta levels in the second CSF sample.

Detailed Summary:
Sponsor: University of Pennsylvania

Current Primary Outcome: Amyloid Beta Levels in CSF [ Time Frame: Two Weeks ]

Change in the level of Amyloid Beta peptides (Amyloid Beta 42 and Amyloid Beta 40) in the CSF between the measurement at baseline and the measurement after 2 weeks of exposure with escitalopram.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Pennsylvania

Dates:
Date Received: June 5, 2014
Date Started: June 2014
Date Completion: December 2017
Last Updated: May 1, 2017
Last Verified: May 2017